Principal CSV Engineer - Automation Engineering

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

Overview:

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

Organization and Position Overview

Lilly recently announced a $4.5 billion investment to create the Lilly Medicine Foundry, a new center for advanced manufacturing and drug development. The first-ever facility of its kind, combining research and manufacturing in a single location, the Medicine Foundry will allow Lilly to further develop innovative solutions to optimize manufacturing processes and increase capacity for clinical trial medicines, while also reducing costs and environmental impact.

This role will work as a member of the Automation Engineering Department at Eli Lilly, Foundry. The engineer will serve as a technical subject matter expert, providing automation support for one or more operating areas across the site and/or for capital projects. This role will provide technical leadership for CSV, leading and executing CSV activities for process automation systems across the site. The engineer will collaborate with cross-functional teams and provide technical expertise and direction in validating systems critical to the manufacture of life-changing products at the new site.

The Engineer is also responsible for ensuring that reliable and compliant control applications and systems are in place and maintained to support manufacturing operations at the Foundry. Additionally, the Engineer will serve as a key technical expert, leading projects and partnering across the Automation Engineering organization and other functional disciplines to influence and implement the process control technical agenda, business plan priorities, and compliance objectives.

In the project delivery phase and startup phase of the project (startup expected 2025 to 2028), automation engineering roles will be fluid and dynamic as we endeavor to support project delivery, build a new organization, develop and implement the necessary systems and business processes required to support GMP operations, and build the site culture. This will require significant collaboration, creativity, and resilience as the site grows to full-scale GMP manufacturing through startup.

Responsibilities

• Lead process control validation testing, implementation, and coordination.

• Lead the development and implementation of the Automation Engineering Project Validation Plan.

• Serve as a subject matter expert for computer system validation and data integrity for automation systems across the site, including Process Automation Systems (DCS, SCADA, BMS, MES, Historian), Building Management System, Vendor Packaged Equipment, Data Historian, Automated Storage and Retrieval System, and QMS.

• Lead and perform risk assessments for computerized systems and develop strategies to mitigate identified risks.

• Lead the development and execution of validation protocols for computerized systems.

• Ensure compliance with regulatory requirements and industry standards (GAMP, 21 CFR Part 11, Data Integrity, etc.) and corporate Lilly quality policies and procedures.

• Lead the generation and maintenance of validation documentation, such as validation plans and summary reports.

• Develop local site procedures (e.g., SOPs, Work Instructions, etc.) related to automation systems.

• Provide technical leadership for change control and deviation management as it pertains to CSV activities.

• Collaborate with vendors to ensure that third-party systems and software meet validation requirements. Conduct vendor audits as needed.

• Provide training and technical guidance to personnel on CSV principles, procedures, and best practices.

• Stay informed of industry trends (e.g., CSA) and advancements in CSV and automation technologies and provide subject matter expertise regarding their application.

• Represent the Automation Department as a technical subject matter expert during audits by regulatory agencies as assigned.

• Act as functional owner for the electronic testing system (Kneat, ALM, ValGenesis), managing CSV documentation relating to automation systems.

Operational Excellence

• Lead the review and oversight of design documentation, including Functional Requirements, Design Specifications, DCS Application Software, Test Specifications, and execution.

• Lead/participate in design reviews and Automation application software reviews to ensure compliance and standardization.

• Provide periodic status updates to Project Management.

• Lead the development of CSV and quality strategies for control systems in collaboration with the Site Quality organization.

• Implement and support electronic systems (such as plant historians) used to capture process automation-related production data.

• Provide technical leadership to maintain the validated state of the site control systems in line with Lilly quality standards, including the development and execution of validation strategies and associated documentation.

• Provide Automation support and technical leadership for capital projects, including new product introductions.

• Promote the use of automation to improve productivity, operational efficiency, and compliance.

• Develop a network of corporate contacts and leverage corporate expertise when needed.

Organizational Capability

• In coordination with automation and compliance consultants, set and reinforce standards for appropriate rigor in automation work products.

• Demonstrated initiative, strong planning and organizational skills, ability to prioritize tasks, and commitment to task completion and timelines.

• Possess a keen technical curiosity and demonstrate strong problem-solving skills and a desire for continuous improvement.

• Demonstrated ability to influence peers and business partners and provide technical leadership across cross-functional teams.

• Strong written and verbal communication skills for both technical and non-technical audiences.

• Strong knowledge of GMP, regulatory requirements, and computer system validation.

Basic Requirements:

• Minimum B.S. in Engineering or related degree and a minimum of 5 years (at the Principal Engineer level) and a minimum of 8+ years' experience (at the Senior Principal level) working experience in Biopharma Automation Engineering, preferably in major pharmaceutical manufacturing.

• Experience with design, development, commissioning, or qualification of computer systems.

Additional Preferences:

• Deep knowledge of GMP/GXP, regulatory requirements, computer system validation, and data integrity.

• Experience in Automation Engineering, preferably in major pharmaceutical manufacturing.

• Experience in design, development, commissioning, and qualification of highly automated greenfield manufacturing sites utilizing SCADA, DCS, MES, LIMS, and Site Historian systems (DeltaV, Rockwell, Syncade, LabVantage, OSI PI).

• Experience in commissioning, qualifying, and supporting systems between SCADA, DCS, MES, LIMS, Historian, and other applications for interconnectivity.

• Experience in design, development, commissioning, and qualification activities ensuring quality compliance and data integrity.

• Experience in facilitating and driving decision-making at an organizational level.

Other Information:

• Initial location in Carmel, IN.

• Permanent location at the new Lilly Medicines Foundry in Lebanon, Indiana.

Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability, or any other legally protected status.

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Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women’s Initiative for Leading at Lilly (WILL).

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is $67,500 - $173,800

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

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